A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors

Inclusion criteria

• Histologically documented locally unresectable or metastatic carcinoid neuroendocrine tumor
• Measurable disease, according to RECIST, with at least one lesion that is unidimensionally measurable by conventional techniques to be greater than or equal to 2 cm in diameter, or by spiral CT to be greater than or equal to 1 cm in diameter
• 18 years or older

Laboratory data to include (next 7 bullet points):

• Aspartate aminotransferase(AST)and alanine aminotransferase (ALT)less than 2.5 times the upper limit of normal (less than 5 times upper limit of normal if liver metastasis present)
• Total bilirubin less than or equal to 2 mg/dL
• Serum creatinine less than or equal to 1.5 mg/dL
• Total white blood cell count greater than 3,500/mm3
• Absolute neutrophil count greater than or equal to 1,500/mm3
• International normalized ratio less then or equal to 1.5
• Platelets greater than or equal to 100,000/mm3
• Agree to use effective contraceptive methods
• Have an ECOG performance status of less than 2
• Life expectancy of greater than 12 weeks
• Ability to understand the requirements of the study, have provided written consent, and agree to abibe by the study restrictions

Exclusion criteria

• Pregnant or nursing, or refusal to use appropriate birth control
• An active infection
• Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 12 months (the patient may be on antianginal medications if the symptoms can be fully controlled), or have uncontrolled congestive heart failure
• Have apparent central nervous system metastasis or carcinomatous meningitis
• Have had any active cancer in addition to the carcinoid tumor within the last 5 years, with the exception of superficial skin cancer
• Be receiving concurrent treatment with therapeutic doses of any anticoagulant including all forms of heparin and Coumadin
• Have current or a history of severe bleeding
• Uncontrolled / severe hypertension
• Previous history of nephrotic syndrome
• Urine protein: creatinine ratio greater than or equal to 1.0 at screening
• Have received radiotherapy or chemotherapy within the previous 4 weeks
• Participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks
• Have had major surgery within 4 weeks or plan to undergo elective surgery during treatment
• Additional uncontrolled serious medical condition or psychiatric illness
• Have any condition that is likely to interfere with regular follow-up